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Completed

NCT Number: NCT06472869

Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening

This study investigates the feasibility, acceptability, and short-term effects of providing 4 weeks of complimentary electronic cigarettes (ECs) to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking. This open-label single-arm pilot clinical trial will test the impact of EC provision on: 1) study feasibility, 2) EC acceptability, 3) tobacco use behavior (e.g., cigarettes per day, EC use), and 4) biomarkers (e.g., carbon monoxide, cotinine, and anabasine). Participants will be asked to switch from combustible cigarettes to the NJOY ACE 5% nicotine electronic cigarette (EC) for 4 weeks. They will be followed an additional 4 weeks after EC provision ends (to 8 weeks).

The first study hypothesis is that more than 40% of eligible smokers who are offered participation in the trial will enroll, and that 75% of enrollees will complete the trial. The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision, relative to their baseline values.

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Key information

Conditions

Electronic Cigarette Use Behavior Chemically-Induced Disorders Cigarette Smoking Mental Disorders Nicotine Dependence Smoking Smoking, Cigarette Substance-Related Disorders Tobacco Smoking Tobacco Use Tobacco Use Disorder Vaping

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who completed the Screen Assist study (NCT03611881) and self-reported smoking cigarettes at the end of the study were asked to complete a survey to ascertain their potential interest in participating in a research study to test the effects of switching from combustible cigarettes (CC) to electronic cigarettes (EC). Individuals who expressed interest in switching to EC on that survey were screened for eligibility for this pilot study
  • Smoked ≥5 cigarettes/day in past month
  • Smoking status at study entry confirmed by breath carbon monoxide (CO) ≥ 6ppm
  • Willing to try switching from CC to EC for 4 weeks
  • Owns a mobile telephone
  • English speaking
  • Willing to travel to the Massachusetts General Hospital campus for 3 in-person visits.

Exclusion criteria

  • Plans to quit smoking and has set a quit date in the next 30 days
  • Used smoking cessation treatment in the past 30 days
  • Used EC on >2 days in the past 30 days
  • Hospitalized for acute coronary syndrome, unstable angina, congestive heart failure, stroke, pneumonia or chronic pulmonary disease/asthma exacerbation in the past 1 month
  • Not willing to abstain from smoking marijuana in the 24h before each study visit

Treatment and study plan

NJOY ACE e-cigarette

Other

Patients will be provided with NJOY ACE electronic cigarettes and 5% nicotine e-liquid cartridges in tobacco flavor for 4 weeks and asked to use the electronic cigarette as a substitute for smoking combustible cigarettes during the 4 weeks

Primary outcomes

  1. Study Feasibility

    Time frame: 4 weeks

    Participant enrollment, measured by the proportion of eligible participants who enroll in the study. Retention is measured by weeks of study participation.

  2. Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision

    Time frame: 4 weeks

    Change in self-reported CPD smoked in the past week assessed using timeline follow-back (TLFB) between baseline and end of e-cigarette provision (Baseline vs.Week 4)

Secondary outcomes

  1. Carbon Monoxide (CO) Concentration in Expired Air

    Time frame: 4 weeks

    Change in participant's expired air carbon monoxide (CO) concentration assessed via Smokerlyzer during the period of e-cigarette provision (Baseline vs.week 4)

  2. Cigarettes Smoked Per Day After E-cigarette Provision Ends

    Time frame: 4 weeks (Weeks 4-8)

    Self-reported number of cigarettes smoked per day in the past week between end of e-cigarette provision and end of study (week 4 to week 8)

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Dana-Farber Cancer Institute
  • University of Massachusetts, Boston

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 25, 2024
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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